Cerebral Palsy Clinical Trial
Official title:
PROMPT to Improve Speech Motor Abilities in Children With Cerebral Palsy
Cerebral palsy (CP) is the most frequent cause of motor disability worldwide, with a prevalence of 2-2.5 per 1000 live births. Children with CP may experience a variety of difficulties with communication including speech. Communication impairment has been identified in at least 40% of children with CP, with 36-90% of CP children experiencing motor speech impairment. The aims of the current project are to test the effectiveness of intensive PROMPT treatment in a group of preschool children with CP and motor speech disorders (dysarthria/apraxia of speech) and to evaluate differences to the intervention response according to CP type, brain lesion severity and white matter integrity of corticospinal tract. We hypothesize that children with CP and motor speech disorders will benefit from 3 weeks of daily administration of PROMPT treatment and show measurable improvement of speech intelligibility on clinical and kinematic assessments, with 3 months stability. Outcome measures will include a standardized speech motor assessment as well as improvement in kinematic speech measures detected by a computerized system. We also hypothesize that children with dyskynetic CP will show more improvement induced by the PROMPT treatment as compared to children with spastic CP. We finally hypothesize that corticospinal microstructural integrity positively impact on intelligibility recovery, with children with better integrity having bigger improvements. Our study of PROMPT with children with varying types of CP meets current international priorities of testing and implementing effective, earlier interventions, therefore investing in the improvement infant's health based on evidence, as a future investment for individuals and the community.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 9 Years |
Eligibility | Inclusion Criteria: - child between 2 and 9 years with a diagnosis of CP, with normal to mild intellectual disability and adequate language comprehension skills - motor speech deficit Exclusion Criteria: - utilization of AAC strategies as the only means of communication, - medical fragility or anatomical malformations affecting speech production preventing the ability to participate in the intervention |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Fondazione Stella Maris | Marina di Pisa-Tirrenia-Calambrone | Toscana |
Lead Sponsor | Collaborator |
---|---|
IRCCS Fondazione Stella Maris |
Italy,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Verbal Motor Production Assessment for Children (VMPAC) | Standardized motor speech assessment, which includes 5 subscales, where higher scores mean better performance: Global motor control (range 20-0); Focal oromotor control (range 268-0); Sequencing (range 46-0); Connected speech and language (range 45-0); Speech Characteristics (range 7-0) | after the end of treatment period (4 weeks from baseline) | |
Primary | Phonetic Inventory | motor speech measure | after the end of treatment period (4 weeks from baseline) | |
Primary | the Intelligibility in Context Scale - Italian version | motor speech measure, range 1-5, where higher scores mean better performances | after the end of treatment period (4 weeks from baseline) | |
Primary | Viking Speech Scale (VSS) | Ordinal scale for intelligibility, range 1-4, with lower scores corresponding to better performances | after the end of treatment period (4 weeks from baseline) | |
Secondary | kinematic speech motor measures | A kinematic analysis of facial movements during simple speech repetition tasks | after the end of treatment period (4 weeks from baseline) |
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